For Patients

Vusion (miconazole nitrate, zinc oxide, and white petrolatum) Ointment is an antifungal used to treat diaper rash caused by a yeast infection. Common side effects of Vusion include burning, irritation, inflammation, pain, dry skin, itching, redness, and rash.

The recommended dosage of Vusion is a thin layer applied to the affected diaper area after being at each diaper change for 7 days. Certain drugs may interact with Vusion. Tell your doctor all medications your child takes. Gently cleanse affected area prior to applying Vusion. Do not use Vusion on infants less than 4 weeks of age. Do not use Vusion to prevent diaper rash. Doing this may cause resistance to the drug. Treatment should continue for 7 days even if there is improvement. Vusion is not indicated for women of child bearing age and should not be used if you are pregnant or breastfeeding.

Our Vusion (miconazole nitrate, zinc oxide, and white petrolatum) Ointment Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

SIDE EFFECTS: Remember that the doctor has prescribed this medication because he or she has judged that the benefit to your child is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell the doctor immediately if this unlikely side effect occurs: increased irritation at the application site.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rate observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

A total of 835 infants and young children were evaluated in the clinical development program. Of 418 subjects in the VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) group, 58 (14%) reported one or more adverse events. Of 417 subjects in the zinc oxide/white petrolatum control group, 85 (20%) reported one or more adverse events. Adverse events that occurred at a rate of ≥ 1% for subjects who were treated with VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) were approximately the same in type and frequency as for subjects who were treated with zinc oxide/white petrolatum ointment.

Post-marketing Experience

The following adverse reactions have been identified during post approval use of VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) .

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.